SurgeryNCT06662266
Induce XT™ Bone Graft in Foot and Ankle Fusion
A study testing Induce XT™ is a mixture of human cortical bone fibers and microparticulates that have been processed into Natural Matrix Protein® (NMP®) to which cancellous bone microparticulates have been added in people with Surgery and Foot Deformities, run by Red Rock Regeneration Inc. at 1 site in Canada.
Trial summary
The goal of this study is to evaluate how effective Induce XT is in patients undergoing foot and/or ankle surgery. Induce XT is a bone graft material used in surgeries to fill gaps where bone is missing, such as during foot and ankle fusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Foot Deformities, Ankle Arthropathy
- What is being tested?
- Induce XT™ is a mixture of human cortical bone fibers and microparticulates that have been processed into Natural Matrix Protein® (NMP®) to which cancellous bone microparticulates have been added
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 12 May 2025to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients meeting all of the following criteria will be considered eligible for study participation:
- Patient has a bone defect in the hindfoot or ankle; and
- Is requiring fusion using an open surgical technique with supplemental bone graft/substitute; and
- Fusion site is able to be rigidly stabilized with no more than 3 screws across the fusion site; and
- Patient is requiring one of the following procedures:
- Ankle joint fusion
Show all 11Show fewer
- Subtalar fusion
- Calcaneocuboid fusion
- Talonavicular fusion
- Triple arthrodesis (subtalar, talonavicular and calcaneocuboid joints)
- Double fusions (talonavicular and calcaneocuboid joints).
Who cannot join
- Patient meeting any of the following criteria will be excluded from study participation:
- Patient is under 18 years of age at the time of consent;
- Patient has an active (local or systemic) infection or is undergoing adjunctive treatment for infection;
- Patient has previous fusion surgery of the proposed fusion site;
- Patient has cognitive disorders or is unable to complete questionnaires or provide consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective Evaluation of Induce XT™ Bone Graft in Foot and Ankle Fusion
The goal of this study is to evaluate how effective Induce XT is in patients undergoing foot and/or ankle surgery. Induce XT is a bone graft material used in surgeries to fill gaps where bone is missing, such as during foot and ankle fusion. Participants in the study will have a screening visit to determine eligibility, followed by an assessment on the day of surgery and 5 follow-up visits over 12 months. These visits will include X-rays, pain evaluations, and questionnaires.
Read the detailed description
Clinical Background Ankle and hindfoot arthrodesis (fusion) is a well-established treatment for various foot and ankle conditions. These surgeries require supplemental graft material. Autogenous bone graft (ABG), typically harvested from sites like the iliac crest bone graft (ICBG), is considered the gold standard for bone grafting. However, the use of ABG presents several challenges, such as increased surgical time, blood loss, and the risk of infection and pain at the donor site. Additionally, the supply of autogenous bone is limited (Boone 2003, Baumhauer, Glazebrook et al. 2020).
Augment® Bone Graft is a substitute used to enhance bone healing in foot and ankle surgeries. It contains recombinant human platelet-derived growth factor BB (rhPDGF-BB) and a beta-tricalcium phosphate (β-TCP) matrix. The β-TCP matrix provides a structure that supports new bone growth, while rhPDGF-BB stimulates the recruitment and proliferation of cells involved in bone formation and promotes both angiogenesis and bone healing. Studies have demonstrated that Augment Bone Graft can be an alternative to ABG in foot and ankle fusion procedures (DiGiovanni, Lin et al. 2013). However, Augment is costly, must be stored at 2 to 8°C, and may handle poorly. It should also not be used in patients with cancer, near resected tumors, or in those who are pregnant or may become pregnant. Additionally, the radiopaque nature of β-TCP can obscure radiographic images, making it difficult to assess bone healing (FDA 2015, FDA 2018).
Demineralized bone matrix (DBM) is another option, used alone or in combination with ABG to support bone fusion. DBM provides a scaffold for new bone growth (osteoconduction) and has osteoinductive properties due to the presence of bone morphogenetic proteins (BMPs), including BMP-2. DBM also contains growth factors that promote angiogenesis and bone formation. However, its clinical effectiveness is limited due to the low amount and bioavailability of growth factors (Gruskin, Doll et al. 2012).
Study Rationale Induce XT is a new bone matrix product combining Natural Matrix Protein® (NMP®) derived from demineralized human cortical bone allograft with mineralized cancellous bone allograft. NMP has demonstrated higher bioavailability of BMP-2 and BMP-7 and enhanced osteoinductive activity compared to DBM in various studies (Kohen, Shivanna, and Peel 2022, Peel 2023). The mineralized cancellous bone component provides additional compression resistance and allows the graft to be seen on radiographs immediately after implantation. Induce XT is clinically used as a bone void filler.
Since its market release in January 2022, NMP bone grafts have been used in over 7,500 surgeries, including spine and foot/ankle fusions, with no reported adverse events. A retrospective study also showed a high fusion rate in lumbar spine procedures using NMP fibers (Nunley 2024).
This prospective clinical trial will enroll 60 patients at one clinical site in Canada to evaluate the safety and efficacy of Induce XT in hindfoot or ankle fusion surgeries. The study will assess radiographic, clinical, functional, and quality-of-life outcomes over a 52-week postoperative period.
- Conditions
- Surgery, Foot Deformities, Ankle Arthropathy
- Being tested
- Induce XT™ is a mixture of human cortical bone fibers and microparticulates that have been processed into Natural Matrix Protein® (NMP®) to which cancellous bone microparticulates have been added
- Medical subject headings
- Foot Deformities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induce XT™ is a mixture of human cortical bone fibers and microparticulates that have been processed into Natural Matrix Protein® (NMP®) to which cancellous bone microparticulates have been addedDevice
Bone graft material is required for successful foot and ankle fusion surgery. Current bone grafting materials include autogenous bone, Augment Bone Graft and demineralized bone matrix (DBM), each of which have limitations.
Induce XT is a novel bone graft material that can potentially be used in foot and ankle fusions that may overcome some of these limitations.
| Study group | Role | What they receive |
|---|---|---|
| Diverse group of participants who require hindfoot or ankle arthrodesis | Other | The selection criteria are designed to ensure that the study population represents the typical patients undergoing these procedures. Receives: Device: Induce XT™ is a mixture of human cortical bone fibers and microparticulates that have been processed into Natural Matrix Protein® (NMP®) to which cancellous bone microparticulates have been added |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Fusion
Fusion as measured by X-Ray
Measured: At 24 and 52 weeks
Percent bridging bone
Measured by Computerized Tomography (CT)
Measured: At 24 and 52 weeks
Secondary outcomes (2)
Disability score for foot and ankle condition
Measured by American Orthopedic Foot and Ankle Society (AOFAS) score 0 to 100 with higher score showing better outcome
Measured: At 24 and 52 weeks
Patient reported health survey
Measured by The Veterans RAND 12-Item Health Survey (VR-12) questionnaire- a self-reported assessment of health with higher scores indicating better perceived health
Measured: At 24 and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start12 May 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Red Rock Regeneration Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sean Peel, Study director, Red Rock Regeneration Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662266
- Sponsor's protocol ID
- CT-NMP-005
- Status last verified
- Nov 2025
- First submitted
- 24 Oct 2024
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Induce XT™ Bone Graft in Foot and Ankle Fusion
- ClinicalTrials.gov ID
- NCT06662266
- Acronym / sponsor ID
- CT-NMP-005
- Conditions
- Surgery, Foot Deformities, Ankle Arthropathy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Red Rock Regeneration Inc.Industry (pharma, biotech, devices)
- Study start
- 12 May 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to evaluate how effective Induce XT is in patients undergoing foot and/or ankle surgery. Induce XT is a bone graft material used in surgeries to fill gaps where bone is missing, such as during foot and ankle fusion. Participants in the study will have a screening visit to determine eligibility, followed by an assessment on the day of surgery and 5 follow-up visits over 12 months. These visits will include X-rays, pain evaluations, and questionnaires.
Detailed description
Clinical Background Ankle and hindfoot arthrodesis (fusion) is a well-established treatment for various foot and ankle conditions. These surgeries require supplemental graft material. Autogenous bone graft (ABG), typically harvested from sites like the iliac crest bone graft (ICBG), is considered the gold standard for bone grafting. However, the use of ABG presents several challenges, such as increased surgical time, blood loss, and the risk of infection and pain at the donor site. Additionally, the supply of autogenous bone is limited (Boone 2003, Baumhauer, Glazebrook et al. 2020).
Augment® Bone Graft is a substitute used to enhance bone healing in foot and ankle surgeries. It contains recombinant human platelet-derived growth factor BB (rhPDGF-BB) and a beta-tricalcium phosphate (β-TCP) matrix. The β-TCP matrix provides a structure that supports new bone growth, while rhPDGF-BB stimulates the recruitment and proliferation of cells involved in bone formation and promotes both angiogenesis and bone healing. Studies have demonstrated that Augment Bone Graft can be an alternative to ABG in foot and ankle fusion procedures (DiGiovanni, Lin et al. 2013). However, Augment is costly, must be stored at 2 to 8°C, and may handle poorly. It should also not be used in patients with cancer, near resected tumors, or in those who are pregnant or may become pregnant. Additionally, the radiopaque nature of β-TCP can obscure radiographic images, making it difficult to assess bone healing (FDA 2015, FDA 2018).
Demineralized bone matrix (DBM) is another option, used alone or in combination with ABG to support bone fusion. DBM provides a scaffold for new bone growth (osteoconduction) and has osteoinductive properties due to the presence of bone morphogenetic proteins (BMPs), including BMP-2. DBM also contains growth factors that promote angiogenesis and bone formation. However, its clinical effectiveness is limited due to the low amount and bioavailability of growth factors (Gruskin, Doll et al. 2012).
Study Rationale Induce XT is a new bone matrix product combining Natural Matrix Protein® (NMP®) derived from demineralized human cortical bone allograft with mineralized cancellous bone allograft. NMP has demonstrated higher bioavailability of BMP-2 and BMP-7 and enhanced osteoinductive activity compared to DBM in various studies (Kohen, Shivanna, and Peel 2022, Peel 2023). The mineralized cancellous bone component provides additional compression resistance and allows the graft to be seen on radiographs immediately after implantation. Induce XT is clinically used as a bone void filler.
Since its market release in January 2022, NMP bone grafts have been used in over 7,500 surgeries, including spine and foot/ankle fusions, with no reported adverse events. A retrospective study also showed a high fusion rate in lumbar spine procedures using NMP fibers (Nunley 2024).
This prospective clinical trial will enroll 60 patients at one clinical site in Canada to evaluate the safety and efficacy of Induce XT in hindfoot or ankle fusion surgeries. The study will assess radiographic, clinical, functional, and quality-of-life outcomes over a 52-week postoperative period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diverse group of participants who require hindfoot or ankle arthrodesis | Other | Device: Induce XT™ is a mixture of human cortical bone fibers and microparticulates that have been processed into Natural Matrix Protein® (NMP®) to which cancellous bone microparticulates have been addedThe selection criteria are designed to ensure that the study population represents the typical patients undergoing these procedures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients meeting all of the following criteria will be considered eligible for study participation:
Key exclusion criteria (5 listed)
- Patient meeting any of the following criteria will be excluded from study participation:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Induce XT™ is a mixture of human cortical bone fibers and microparticulates that have been processed into Natural Matrix Protein® (NMP®) to which cancellous bone microparticulates have been addedBone graft material is required for successful foot and ankle fusion surgery. Current bone grafting materials include autogenous bone, Augment Bone Graft and demineralized bone matrix (DBM), each of which have limitations. Induce XT is a novel bone graft material that can potentially be used in foot and ankle fusions that may overcome some of these limitations. | Device | Diverse group of participants who require hindfoot or ankle arthrodesis |
Primary outcome
Bone Fusion
Time frame: At 24 and 52 weeks
Fusion as measured by X-Ray
Percent bridging bone
Time frame: At 24 and 52 weeks
Measured by Computerized Tomography (CT)
2 secondary outcomes
Disability score for foot and ankle condition
Time frame: At 24 and 52 weeks
Patient reported health survey
Time frame: At 24 and 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sean Peel study director
Red Rock Regeneration Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Induce XT™ is a mixture of human cortical bone fibers and microparticulates that have been processed into Natural Matrix Protein® (NMP®) to which cancellous bone microparticulates have been added in people with Surgery and Foot Deformities, run by Red Rock Regeneration Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Fusion (time frame: At 24 and 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.